The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. Associate Director – Regulatory Affairs. Establish regulatory st...
Reporting to the SVP, Regulatory Affairs, the Senior Manager or Associate Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA preparations and maintenance to support new and ongoing development programs. Provide oversight of regulatory submission...
Consumer Products Litigation & Regulatory Associate. The associate hired for this position will focus primarily on regulatory matters, including those involving the CPSC, FTC, and NAD. Affirmative regulatory reporting and responding to regulatory investigations. Dentons’ Consumer Products team h...
The Associate Director, Regulatory Affairs is responsible for establishing regulatory strategies in coordination with departmental leadership, and independently managing life cycle plans along with regulatory submissions and approvals. Comprehensive knowledge of current US and ex-US regulations and ...
The position is responsible for leading CMC regulatory activities within the Regulatory Affairs department, to support all ORIC’s clinical development programs of oncology products. Oversee and direct all CMC regulatory strategies in compliance with global regulatory requirements for the development...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
At least 8+ years of regulatory affairs experience for the associate director or 10+ years of regulatory affairs experience for the director in the pharmaceutical or biotechnology industry. Lead to deliver high quality and timely regulatory submissions in alignment with corporate goals, and in compl...
The Regulatory Associate will primarily focus on provider reimbursement issues, Medicare and Medicaid appeals, and audits and internal investigations, supporting the firm's robust and sophisticated regulatory and reimbursement practices. A leading national healthcare law firm is seeking a Regulatory...
The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
The Associate Director of Regulatory Affairs will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and De Novo submissions. Job Title: Associate Director of Regulatory Affairs. Conduct regulatory assessments for product change...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
Develop, implement, and update procedural and training manuals for the Regulatory Associates and Regulatory Department. Work closely and collaboratively with clinical project management staff to plan and delegate collaborative tasks for study coordinators and regulatory associates to ensure completi...
The Director of Regulatory Affairs & Quality will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities. Leading Regulatory Affairs strategy end-to-end executio...
Regulatory Affairs Specialist w/ Dexcom Inc. ...
American Specialty Health Incorporated is seeking a Specialist - HR Compliance to join our Human Resources (HRS) department. This position will oversee HR Compliance, lead HR audit efforts, oversee the Immigration Process and create and maintain standard operating procedures (SOPs). Researches, docu...
Maravai LifeSciences is seeking a #MiracleMaker to join our Finance and Accounting team as a Senior SOX Compliance Analyst. As a Senior SOX Compliance Analyst, you will be responsible for assisting with risk assessments, control design, helping control owners anticipate testing and documentation req...
Providing environmental and technical assistance to support the BRAC Lead Remedial Project Manager with project oversight, including data collection, regular interface, cost estimate development, preparation of statements of work, and drafting correspondence according to established milestones with ...
Communication: Effective communication is crucial in project management, and the Project Manager must be able to clearly convey project updates, expectations, and objectives to all stakeholders. Time-management: With multiple projects and deadlines, the Project Manager must be able to prioritize tas...
We are seeking a motivated and experienced Creative Project Manager to join our growing Creative Studio team, reporting into the Head of Creative Studio. Identify and assign work to the best suited resources, build project plans, and coordinate schedules for timely project completion. Update the app...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience in the past with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand h...
The Senior Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. Senior Regulatory Affairs Specialist. In this pivotal role, you will leverage your expertise to navigate complex regulatory landscapes, ensuring our groundbreaking ...
Represents the Regulatory Affairs department as a member of project teams, certain boards, and as part of other meetings as the need arises. Providing regulatory affairs support for all aspects of product development and manufacturing. Evaluating proposed engineering, manufacturing, labeling and qua...
You are a seasoned professional in the Regulatory Affairs space with specific experience with IVD and POC products. You have experience with US regulatory affairs submissions such as 510(k) and/or PMA. Have previous experience with various regulatory affairs submissions. You understand how to take t...
Prepare the team for and participate in regulatory inspections or other official engagements related to Cibus Regulatory Compliance Program, demonstrating Cibus compliance with regulatory requirements and Cibus internal standards. Regulatory Compliance Specialist. Cibus has an immediate opening for ...